MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401091
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed that the core wire was broken, kinked and unraveled.Additionally, the coil wire was found stretched and kinked in different sections.It was found during the investigation of the returned guidewire that the distal tip was observed with the corewire fracture.The issues noted could have been generated by user, also by the interaction with other devices might have impacted the integrity of the device during the procedure.On the other hand, all outer diameters were found within specification.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff guidewire was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the guidewire unraveled.The procedure was completed using a non bsc guidewire.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: corewire broken.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9069869
• Report Number: 3005099803-2019-04581
• Device Sequence Number: 2475423
• Product Code: EZB
• UDI-Device Identifier: 08714729191193
• UDI-Public: 08714729191193
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2022
• Device Model Number: M0066401091
• Device Catalogue Number: 640-109
• Device Lot Number: 0023312169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1